BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADM SUPPORT POUR PRESSE INSERT

    MDR report key: 1811510 · Received August 17, 2010

    Report

    Report Number
    9610669-2010-00088
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 24, 2010
    Report Date
    July 27, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CAEN
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "WE FOUND THE ADM PRESS STAND ((B)(4)) TO BE LOCKED INTO THE ADM PRESS ((B)(4)). THE BIG POST ON THE STAND SHOULD FIT INTO THE PRESS AND ALLOW FOR SOME ROTATIONAL MOVEMENT. HOWEVER, THIS ITEM WAS PRESSURE LOCKED IN AND WOULD NOT BUDGE. WE GOT THE ITEMS SEPARATED AND IT WOULD NOT FIT BACK INTO THE PRESS. WE TRIED THIS STAND IN A DIFFERENT PRESS AND IT STILL WOULDN'T WORK. WE ALSO TRIED PUTTING A DIFFERENT PRESS STAND INTO THE SAME PRESS THAT DID WORK. THROUGH DEDUCTION WE FOUND, THE STAND IS BROKEN (SPECIFICALLY THE POST ON THE STAND).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADM SUPPORT POUR PRESSE INSERT INSTRUMENT LXH STRYKER ORTHOPAEDICS CAEN NA G2948934

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention